Skip to main content

ISO 15676:2016

Current Date published:

Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document is applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. <6 h duration) CPB surgery or (long-term, i.e. >24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as "sterile".

It is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.

Get this standard Prices exclude GST
PDF ( Single user document)
$118.26 NZD
Networkable PDF
Price varies
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 8

Previous versions

Keep me up-to-date

Register to receive notifications when updates are made to this standard.

Related Information

Similar Standards

  • AS/NZS 2817:1997

    Implants for surgery - Care and handling of orthopaedic implants

  • BS 2574-1:1991

    Lower limb orthoses, Guide to the design and manufacture of lower limb orthoses, excluding foot orthoses

  • BS 2574-2:1994

    Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses

  • BS 3531-11:1991

    Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs

Preview only close
Prev {{ page }}/ {{ numPages }} Next
Preview only close
Prev {{ page }}/ {{ numPages }} Next
Pages: 8

Previous versions

ISO 15676:2016

Get this standard Prices exclude GST
PDF ( Single user document)
$118.26 NZD
Networkable PDF
Price varies

Request to add this standard to your subscription

ISO 15676:2016

Price varies
Online library subscription

Click "Send request for subscription" to ask your Account Administrator to add this standard to your subscripiton.

Cancel